Efficacy of Exenatide-LAR and Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Type 2 Diabetes

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT02811484
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Exenatide-LAR plus Dapagliflozin placebo — DRUG
    Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy.
  • Exenatide-LAR plus Dapagliflozin — DRUG
    Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin 5 mg x 2 weeks, then 10 mg for 22 weeks and behavioral therapy.
  • Insulin Titration — DRUG
    Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c\>8%
  • Behavioral Therapy — BEHAVIORAL
    Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program.

Study Details

The purpose of this study is to see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking insulin. This research study is being done to investigate which of these commonly-used medications, medication combinations or increasing insulin dose is better.

Key Dates

Start date
Jun 30, 2016
Status verified
Mar 2017
Primary completion
Jun 30, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Other: Group 1
    Insulin titration and behavioral therapy.
  • Placebo Comparator: Group 2
    Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy.
  • Experimental: Group 3
    Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy.

Primary Outcome Measure

Change in HbA1c [ Time Frame: baseline, 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Comprehensive Weight Control CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Comprehensive Weight Control Center· New York, NY

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